Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586859
Recruitment Status : Terminated (Sponsoring company ceased business operations.)
First Posted : January 7, 2008
Last Update Posted : May 30, 2008
Information provided by:
NDO Surgical, Inc.

Brief Summary:

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.

Condition or disease Intervention/treatment
GERD Device: NDO Full-thickness Plicator

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
Study Start Date : May 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Arm Intervention/treatment
Experimental: A
NDO Full-thickness Plicator Procedure
Device: NDO Full-thickness Plicator
The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.

Primary Outcome Measures :
  1. GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-month post-treatment ]

Secondary Outcome Measures :
  1. Heartburn Score [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ]
  2. Regurgitation score [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ]
  3. GERD symptom improvement as measured by a visual analog scale [ Time Frame: 1, 6, 12. 24, 36, 48 and 60-months post-treatment ]
  4. GERD medication use [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ]
  5. Esophageal acid exposure [ Time Frame: 6-months post-treatment ]
  6. Esophageal sphincter (LES) resting pressure as measure by manometry [ Time Frame: 6-months post-treatment ]
  7. Esophagitis score [ Time Frame: 6-months post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is 18 years of age or older.
  • History of heartburn or regurgitation for at least 6 months.
  • Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
  • pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
  • Symptoms requiring daily PPI therapy.
  • GERD-HRQL scores must be > 15 while Off Medication and Off Medication scores must be > 6 points higher than On-Medication scores.
  • Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
  • Subject agrees to participate and signs consent form.

Exclusion Criteria:

  • Patient is pregnant.
  • Patient has hiatal hernia > 3 cm.
  • Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
  • Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
  • Barrett's esophagus with dysplasia.
  • Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
  • Active medical condition that would preclude the subject from finishing this study.
  • Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
  • Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
  • Presence of esophageal or gastric varices.
  • Esophageal dysmotility as determined by manometry studies.
  • Esophageal stricture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586859

Evangelisches Krankenhaus
Dusseldorf, Germany, 40217
Frankfurt, Germany, 60431
Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig
Leipzig, Germany, D-04103
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Sponsors and Collaborators
NDO Surgical, Inc.

Responsible Party: Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical Identifier: NCT00586859     History of Changes
Other Study ID Numbers: 135-02420
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by NDO Surgical, Inc.:
Gastroesophageal Reflux Disease (GERD)
NDO Full-thickness Plicator
Endoluminal GERD Therapy